R&D Quality Strategy Lead

Compensation: $160K ~$195K base + 20% bonus + LTI eligibility

A global biopharmaceutical organization is looking for an experienced R&D Quality professional to serve as a strategic quality partner across development programs.

This is a senior-level role focused on bringing quality strategy, risk management, compliance, and inspection readiness into the drug development process. The position will partner closely with Clinical Development, Data Management, Biostatistics, Regulatory Affairs, and other R&D functions while working with senior stakeholders and external partners.

• Develop and implement quality strategies for assigned development programs.
• Provide quality leadership and guidance throughout the product development lifecycle.
• Identify emerging quality risks, gaps, and trends and drive appropriate mitigation strategies.
• Lead or oversee risk assessments, audit strategy, and other quality activities.
• Support deviation investigations, root cause analysis, CAPA, and significant compliance issues.
• Lead inspection-readiness activities and support health authority inspections from preparation through closeout.
• Partner with clinical development, data management, biostatistics, regulatory affairs, vendors, and investigational sites.
• Provide quality insight and compliance metrics to support strategic decision-making.
• Support due diligence and other key business decisions from a quality perspective.
• Drive continuous improvement, quality-by-design, and consistent quality practices across development programs.
• Help strengthen quality procedures, guidance, audit tools, and clinical trial oversight practices.

• Bachelor's degree in a scientific or quality-related discipline required; advanced degree preferred.
• 10+ years of experience in Quality Assurance or a related pharmaceutical/biotechnology environment.
• Strong experience with GCP and global clinical development requirements.
• Demonstrated understanding of drug development and clinical trial processes.
• Experience with quality risk management, audits, inspection readiness, root cause analysis, and CAPA.
• Ability to operate strategically and influence senior stakeholders in a matrixed organization.
• Strong communication and stakeholder-management skills.
• Experience working across multiple GxP areas or global development programs is highly valued.

The strongest candidates will come from R&D Quality, Clinical Quality, Clinical QA, GCP Quality, or related quality leadership backgrounds within pharmaceutical or biotechnology organizations.

This is a hybrid role requiring three days onsite each week in Billerica, MA.